This pilot study showed no statistically significant treatment effect from fluid administration, but does not exclude the possibility of a clinically important treatment effect” Jones et al (2018).
Study objective: The objective of this pilot study is to assess the feasibility and necessity of performing a large-scale trial to measure the effect of intravenous fluid therapy on migraine headache pain.
Methods: This was a single-center, pilot randomized controlled trial. We randomized adult emergency department migraine headache patients to receive 1 L of normal saline solution during 1 hour (fluid group) or saline solution at 10 mL/hour for 1 hour (control group). All patients received intravenous prochlorperazine and diphenhydramine at the start of fluid administration. Participants and outcome assessors were blinded; nurses administering the intervention were not. Outcomes were assessed at 60 and 120 minutes, and 48 hours. The primary outcome was the difference in the verbal pain rating (on a scale of 0 to 10) between 0 and 60 minutes. Key secondary outcomes included additional clinical endpoints, the rate of protocol completion, and the effectiveness of blinding.
Results: Fifty patients consented to participate; one withdrew, leaving 25 patients randomized to the fluid group and 24 in the no fluid group. The mean improvement in 0- to 60-minute pain score was 4.5 (95% confidence interval 3.7 to 5.3) in the fluid group and 4.9 (95% confidence interval 3.5 to 6.2) in the control group. Primary outcome data were collected for 49 of 50 enrolled patients, and only one participant correctly identified the group assignment.
Conclusion: This pilot study showed no statistically significant treatment effect from fluid administration, but does not exclude the possibility of a clinically important treatment effect. The study protocol and approach to blinding are both feasible and effective.
You may also be interested in…
Jones, C.W., Remboski, L.B., Freeze, B., Braz, V.A., Gaughan, J.P. and McLean, S.A. (2018) Intravenous Fluid for the Treatment of Emergency Department Patients With Migraine Headache: A Randomized Controlled Trial. Annals of Emergency Medicine. October 26th. .